“Preservative-Free” Claim may be banned in China

“Preservative-Free” cosmetics are at the edge of the cliff in China. 

CosmeticsBridge Alerts

According to the insight of the CosmeticsBridge, the filing/Notification of China cosmetics brand’s new Skin Rejuvenating product was just rejected by the National Medical Products Administration(NMPA). The rejection opinions show “it is a water-based formula, but no permitted use preservatives are added, which may lead to the risk of spoilage and deterioration of the product during the shelf life. Please provide additional evidence to ensure product quality during the shelf life. “.

It should be noted that the “preservatives” mentioned in the rejection feedback refer to “permitted use preservatives”. In December 2015, China FDA (Now NMPA) issued the “Cosmetics Safety Technical Standards” (2015 Edition) in which Chapter 3, Table 4, is a list of preservatives for use in China, and a total of 51 preservatives are included. In the list, it is clearly defined the types of preservatives, the maximum allowable concentration, the scope of use, restrictions, and labeling requirements

The “Preservatives Free” claim on the market today mainly refers to the products without the above-mentioned permitted preservatives, but in fact, other ingredients have the same functions as so-called “off-table preservatives”.

According to the rejection opinions, the only window to the success notification is to provide additional evidence to ensure product quality during the shelf life. We reasonably believe a complete challenge testing report can do the job, in this case, to prove the product will not deteriorate within the validity shelf life.

However, according to another rejection case from a different province as the following table shows, the local NMPA directly rejected the case because they can not find the permitted use of preservatives and suggested adjusting the formula. This means off-table preservatives are completely off the table in this province.

Searching for the keyword “Preservative-Free” on Xiaohongshu, the largest social platform for cosmetics found that there are more than 200,000 related notes such as “preservative-free facial mask” and “preservative-free cream”. 

There are two main types of cosmetics that claim to be free of preservatives: 

1. the products do not contain preservatives, and most of them are disposable packaging products (such as disposable, capsules)  and products that are not easy to breed microorganisms (such as perfume, dry powder, etc. ); 

2. The product is using unapproved preservatives, that is, we called off table preservatives. More and more NMPA experts believe this is unsafe behavior and can not tolerate.

According to our research, currently common “off the table preservatives” include p-hydroxyethyl ketone, organic acids (such as capryloylhydroxamic acid, anisic acid), polyols (such as pentanediol, butanediol) ), polar amphiphiles with medium carbon chains (such as ethylhexylglycerol, glycerol caprylate), etc.

“But there is no evidence that off-table preservatives are safer than permitted preservatives”, a senior NMPA regulatory expert pointed out. “If they can meet the conditions and the relevant technical requirements, they will be included in the Safety Standards.

On December 28, 2020, the NMPA issued the “Announcement on Approving the Use of 4 Raw Materials including Lauroyl Arginine Ethyl Ester HCl as Cosmetic Raw Materials”, approving lauroyl arginine ethyl ester HCl as a cosmetic preservative.  

In conclusion, we highly believe “off-table preservatives” are rarely able to be added to cosmetics to serve antisepsis functions in the future, which leads to the “Preservatives Free” claims being literally banned in China.

Contact us for solutions if you have similar claims and want to register products in China.